Instrument IMTRRHP-EXSM
GUDID 05060296236175
Rotating Hinge Polyethylene Reamer: Extra-Small
Stanmore Implants Worldwide Ltd
Bone-resection orthopaedic reamer, reusable| Primary Device ID | 05060296236175 |
| NIH Device Record Key | 8a01416c-1eb9-4317-b5da-771e733de1fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Instrument |
| Version Model Number | imtrrhp/ExSm |
| Catalog Number | IMTRRHP-EXSM |
| Company DUNS | 494989502 |
| Company Name | Stanmore Implants Worldwide Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060296236175 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133152
FDA Product Code
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
[05060296236175]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-07-23 |
| Device Publish Date | 2019-07-18 |
On-Brand Devices [Instrument]
| 05060296236328 | Passive Hinge Reamer STD |
| 05060296236311 | Passive Hinge Reamer SM |
| 05060296236304 | Passive Hinge Reamer XSM |
| 05060296236175 | Rotating Hinge Polyethylene Reamer: Extra-Small |
| 05060296236151 | Rotating Hinge Metal-Cased Reamer: Extra-Small |
| 05060296233860 | Rotating Hinge Polyethylene Reamer: Standard |
| 05060296233846 | Rotating Hinge Polyethylene Reamer: Small |
| 05060296233778 | Rotating Hinge Metal-Cased Reamer: Small |
| 05060296233761 | Rotating Hinge Metal-Cased Reamer: Standard |
| 05060296233709 | Fixed hinge Reamer |
| 05060296236489 | Customs Tibial Cutting Guide Lid |
| 05060296236472 | Customs Tibial Cutting Guide Tray |
| 05060296236465 | Insert - Extra Small Customs Tray |
| 05060296236458 | Base - Extra Small Customs Tray |
| 05060296236441 | Insert - Small Customs Tray |
| 05060296236434 | Base - Small Customs Tray |
| 05060296236427 | Common Lid - Transparent |
| 05060296236410 | Insert - Standard Customs Tray |
| 05060296236403 | Base - Standard Customs Tray |
| 05060296236250 | Trial Axle STD |
| 05060296236243 | Trial Axle SM |
| 05060296236236 | Trial Axle XSM |
| 05060296236229 | Trial Tibial Plateau Plate: 20mm Extra-Small |
| 05060296236212 | Trial Tibial Plateau Plate: 15mm Extra-Small |
| 05060296236205 | Trial Tibial Plateau Plate: 10mm Extra-Small |
| 05060296236199 | Trial Tibial Plateau Plate: 5mm Extra-Small |
| 05060296234430 | Trial Tibial Plateau Plate: 20mm Small |
| 05060296234423 | Trial Tibial Plateau Plate: 15mm Small |
| 05060296234416 | Trial Tibial Plateau Plate: 10mm Small |
| 05060296234409 | Trial Tibial Plateau Plate: 5mm Small |
| 05060296234393 | Trial Tibial Plateau Plate: 5mm Standard |
| 05060296234386 | Trial Tibial Plateau Plate: 10mm Standard |
| 05060296234379 | Trial Tibial Plateau Plate: 15mm Standard |
| 05060296234362 | Trial Tibial Plateau Plate: 20mm Standard |
| 05060296236380 | Axle cap introducer |
| 05060296236373 | Passive EXSM Positioning Plate: Slots |
| 05060296236366 | Passive SM Positioning Plate: Slots |
| 05060296236359 | Passive STD Positioning Plate: Slots |
| 05060296236342 | EXSM Positioning Plate: Slots |
| 05060296236335 | EXSM Positioning Plate: Holes |
| 05060296236168 | Cutting Guide Fixation Pin |
| 05060296236137 | Bush Compressor: Extra-Small |
| 05060296236120 | Face Cutter Body & Spigot |
| 05060296236113 | Alignment Tool 50, 70, & 90mm |
| 05060296233822 | Tibial Cutting Guide: Prongs |
| 05060296233815 | Tibial Cutting Guide: Rest |
| 05060296233808 | Tibial Cutting Guide: Rod |
| 05060296233747 | STD Positioning Plate: Slots |
| 05060296233730 | STD Positioning Plate: Holes |
| 05060296233723 | SM Positioning Plate: Slots |
Trademark Results [Instrument]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSTRUMENT 86648787 not registered Dead/Abandoned |
Wright, Bruce David 2015-06-02 |
 INSTRUMENT 86251255 4640905 Live/Registered |
INSTRUMENT LLC 2014-04-14 |
 INSTRUMENT 85068560 not registered Dead/Abandoned |
Instrument Skateboards LLC 2010-06-22 |
 INSTRUMENT 77742928 3725465 Dead/Cancelled |
Instrument Marketing, Inc. 2009-05-22 |
 INSTRUMENT 74508227 not registered Dead/Abandoned |
Pro Golf of America, Inc. 1994-04-04 |
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